If you’re interested in new tech and innovation – including outside of the biopharma space – and enjoy warm weather and coastlines, you won’t help but envy Ravi Kiron. Merck KGaA has given him the job of all jobs. Kiron has became the head of biopharma external innovation at Merck’s EMD Serono, Inc., and tasked with establishing its Silicon Valley Innovation Hub. Try not to be too jealous of Kiron as you’re reading. More jobs like his may be on the way.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
Larger CDMOs are broadening their scale and services to fill strategic gaps by building a mosaic comprised of smaller, focused-service providers. This trend is effectively increasing the size and scope of the large global end-to-end CDMOs, while reducing the number of small and midsize service providers. Has a void has been created?
Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
According to the World Health Organization (WHO), the prevalence of spurious, falsely-labelled, falsified, or counterfeit medicines, or SFFC medicines as they are known — medicines that are deliberately and fraudulently produced, packaged and/or mislabeled — is a growing trend worldwide which threatens both patient safety as well as public confidence in the health systems and regulatory bodies designed to provide oversight and control.
The increasing demand for monoclonal antibodies (MAb) as biopharmaceuticals has promoted the development of cell cultures with increased expression levels. As a consequence, the demand for more effi cient purifi cation processes has increased. This application note describes a two-step process for MAb purifi cation based on MabSelect SuRe™ and Capto™ adhere, a strong multimodal anion exchanger. By GE Healthcare
ÄKTA start eliminates the hassles of manual protein purification handling, such as loading large sample volumes and continually monitoring UV readings, and can give you consistency of yield and purity. Madhu demonstrates how ÄKTA start aided him in purifying a recombinant N-terminal histidine-tagged protein.
Disposable bioreactors have gained widespread acceptance in cell culture applications because they provide a flexible resource for multiproduct facilities and speed the production of biomolecules.
Biopharmaceutical manufacturer’s goals are to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial manufacturing. Traditionally, column packing has been considered a bottleneck. Suboptimal packing is not only time-consuming, but can result in poor performance. By eliminating these two concerns, you can focus on the core process.
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With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.
When selecting a bioreactor, you can choose stainless steel or single-use technologies, depending on your biomanufacturing requirements. The bioreactor is a key component of your bioprocessing workflow and should be regarded as a strategic asset. It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways.